Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Kendall DL Adapter, 3 and 5-Lead, For Draeger M540 Monitors, Reusable
Cardinal Health 200, LLC
33551
In Commercial Distribution

  • 50885380166219 ()
  • 10885380166211 ()
  • 00885380166214 ()
33551

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33534
In Commercial Distribution

  • 20884527022110 ()
  • 10884527022113 ()
33534-

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33533
In Commercial Distribution

  • 20884527022103 ()
  • 10884527022106 ()
33533-

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33532
Not in Commercial Distribution

  • 20884527022097 ()
  • 10884527022090 ()
33532

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33531
In Commercial Distribution

  • 20884527022080 ()
  • 10884527022083 ()
33531

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33530
In Commercial Distribution

  • 20884527022066 ()
  • 10884527022069 ()
33530

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33529
In Commercial Distribution

  • 20884527022042 ()
  • 10884527022045 ()
33529-

  • Electrocardiographic lead switching adaptor
DL 17 Pin Adapter,3 Lead
Cardinal Health, Inc.
33510
In Commercial Distribution

  • 20884527021502 ()
  • 10884527021505 ()
  • 30884527021509 ()
33510

  • Electrocardiographic lead switching adaptor
DL 17 Pin Adapter,5 Lead
Cardinal Health, Inc.
33509
Not in Commercial Distribution

  • 20884527021496 ()
  • 10884527021499 ()
  • 30884527021493 ()
33509

  • Electrocardiographic lead switching adaptor
DL 8 Pin Adapter,3/5 Lead
Cardinal Health, Inc.
33508
In Commercial Distribution

  • 20884527021489 ()
  • 10884527021482 ()
  • 30884527021486 ()
33508

  • Electrocardiographic lead switching adaptor
DL 12 Pin Adapter,3/5 Lead
Cardinal Health, Inc.
33507
In Commercial Distribution

  • 20884527021472 ()
  • 10884527021475 ()
  • 30884527021479 ()
33507

  • Electrocardiographic lead switching adaptor
DL 11 Pin Adapter,5 Lead
Cardinal Health, Inc.
33506
In Commercial Distribution

  • 20884527021465 ()
  • 10884527021468 ()
  • 30884527021462 ()
33506

  • Electrocardiographic lead switching adaptor
DL 11 Pin Adapter,12 Lead
Cardinal Health, Inc.
33505
In Commercial Distribution

  • 20884527021458 ()
  • 10884527021451 ()
  • 30884527021455 ()
33505

  • Electrocardiographic lead switching adaptor
DL 6 Pin Adapter,3 Lead, Resistors
Cardinal Health, Inc.
33504
In Commercial Distribution

  • 20884527021441 ()
  • 10884527021444 ()
  • 30884527021448 ()
33504

  • Electrocardiographic lead switching adaptor
DL 6 Pin Adapter,5 Lead, Resistors
Cardinal Health, Inc.
33503
In Commercial Distribution

  • 20884527021434 ()
  • 10884527021437 ()
  • 30884527021431 ()
33503

  • Electrocardiographic lead switching adaptor
DL 6 Pin Adapter,3 Lead (1355), No Resistors
Cardinal Health, Inc.
33502
In Commercial Distribution

  • 20884527021427 ()
  • 10884527021420 ()
  • 30884527021424 ()
33502

  • Electrocardiographic lead switching adaptor
DL Adapter 3 Lead
Cardinal Health, Inc.
33550T
In Commercial Distribution

  • 20884521751276 ()
  • 10884521751279 ()
  • 30884521751273 ()

  • No;
33550T

  • Electrocardiographic lead switching adaptor
DL Adapter 3 or 5 Lead
Cardinal Health, Inc.
33547T
In Commercial Distribution

  • 20884521751269 ()
  • 10884521751262 ()
  • 30884521751266 ()

  • No;
33547T

  • Electrocardiographic lead switching adaptor
No Description
AALTO SCIENTIFIC
K982M-5
In Commercial Distribution

  • B085K982M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K936M-5
In Commercial Distribution

  • B085K936M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K935M-5
In Commercial Distribution

  • B085K935M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K908M-5
In Commercial Distribution

  • B085K908M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K906M-5
In Commercial Distribution

  • B085K906M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K891M-5
In Commercial Distribution

  • B085K891M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K887M-5
In Commercial Distribution

  • B085K887M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K804M-5
In Commercial Distribution

  • B085K804M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K710M-5
In Commercial Distribution

  • B085K710M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K026M-6
In Commercial Distribution

  • B085K026M60 ()


  • Multiple cardiac marker IVD, control
Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.
International Point of Care Incorporated
CSC3023
Not in Commercial Distribution

  • B103CSC30231 ()
  • B103CSC30230 ()
CSC3023

  • Multiple cardiac marker IVD, control
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS1002
Not in Commercial Distribution

  • B103A25CS10021 ()
  • B103CS10020 ()
CS1002

  • Troponin I IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS1002
Not in Commercial Distribution

  • B103A20CS10021 ()
  • B103CS10020 ()
CS1002

  • Troponin I IVD, kit, rapid ICT, clinical
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
International Point of Care Incorporated
CS1002
Not in Commercial Distribution

  • B103A10CS10021 ()
  • B103CS10020 ()
CS1002

  • Troponin I IVD, kit, rapid ICT, clinical
Arrow-Johans(TM) ECG Adapter for Right Atrial Electrocardiography (RAECG)
TELEFLEX INCORPORATED
IPN924190
In Commercial Distribution

  • 30801902208874 ()
  • 20801902208877 ()
  • 10801902208870 ()
EG-04900

  • Electrocardiographic lead switching adaptor
Sheath Adapter with Cath-Gard(R) Catheter Contamination Shield for use with 4 - 7 Fr. Catheters
TELEFLEX INCORPORATED
IPN924153
In Commercial Distribution

  • 20801902208532 ()
  • 10801902208535 ()
SA-09847

  • Electrocardiographic lead switching adaptor
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma
NANO-DITECH CORPORATION
TF3154
In Commercial Distribution

  • 00895160002496 ()
  • 10895160002493 ()
TF3154

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasma and serum
NANO-DITECH CORPORATION
CD7140
Not in Commercial Distribution

  • 00895160002113 ()
  • 00895160002110 ()
CD7140

  • Troponin I IVD, kit, rapid ICT, clinical
In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma
NANO-DITECH CORPORATION
CD7141
In Commercial Distribution

  • 00895160002076 ()
  • 10895160002073 ()
CD7141

  • Troponin I IVD, kit, rapid ICT, clinical
Alere Triage® Troponin I Test
ALERE SAN DIEGO, INC.
98600EU
Not in Commercial Distribution

  • 00893038002821 ()
98600EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio3 Panel
ALERE SAN DIEGO, INC.
97400EU
Not in Commercial Distribution

  • 00893038002807 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HS
Not in Commercial Distribution

  • 00893038002197 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel, CK-MB and TnI
ALERE SAN DIEGO, INC.
97022HS
Not in Commercial Distribution

  • 00899722002795 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel, TnI
ALERE SAN DIEGO, INC.
97021HS
Not in Commercial Distribution

  • 00899722002788 ()
97021HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Profiler SOB™ Panel
ALERE SAN DIEGO, INC.
97300EU
Not in Commercial Distribution

  • 00899722002740 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HSEU
Not in Commercial Distribution

  • 00899722002719 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
OneStep Troponin I RapiCard™ InstaTest (Serum/WB) A collection of reagents and other associated materials intended to be used for the qualitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
Diagnostic Automation, Inc.
DACD166772-1-19
In Commercial Distribution

  • 00894175000466 ()
  • 00894175000442 ()

  • 25 tests
166772-1-19

  • Troponin I IVD, kit, rapid ICT, clinical
CARDIAC MARKER CONTROL TRI-LEVEL
CLINIQA CORPORATION
91484
In Commercial Distribution

  • 00817238010080 ()


  • Multiple cardiac marker IVD, control
CARDIAC MARKER CONTROL +TnI Level 3
CLINIQA CORPORATION
91483
In Commercial Distribution

  • 00817238010073 ()


  • Multiple cardiac marker IVD, control
Cardiac Marker Control +TnI Level 2
CLINIQA CORPORATION
91482
In Commercial Distribution

  • 00817238010066 ()


  • Multiple cardiac marker IVD, control
Liquid QC Cardiac Marker Control +TnI Level 1
CLINIQA CORPORATION
91481
In Commercial Distribution

  • 00817238010059 ()


  • Multiple cardiac marker IVD, control
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